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510(k) K203270

IMMULITE/IMMULITE® 1000 Cortisol by Siemens Healthcare Diagnostics Products, Ltd. — Product Code CGR

K203270 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics Products, Ltd. for the device "IMMULITE/IMMULITE® 1000 Cortisol". The FDA issued a decision of Substantially Equivalent on January 15, 2021. The device falls under product code CGR (Radioimmunoassay, Cortisol), a Class II device regulated under 21 CFR 862.1205. Siemens Healthcare Diagnostics Products, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 2021
Date Received
November 5, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Cortisol
Device Class
Class II
Regulation Number
862.1205
Review Panel
CH
Submission Type

Other clearances by Siemens Healthcare Diagnostics Products, Ltd.

  • K240315 — INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Api (October 10, 2024)
  • K233946 — IMMULITE® 2000 BR-MA (March 13, 2024)
  • K233663 — N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) (December 13, 2023)
  • K213510 — IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA (September 8, 2023)
  • K220728 — vWF Ag (June 2, 2023)
  • K212559 — CardioPhase® hsCRP (December 16, 2022)
  • DEN200067 — INNOVANCE VWF Ac (September 29, 2022)
  • K212379 — N Latex FLC kappa, N Latex FLC lambda (March 2, 2022)
  • K201496 — N Latex FLC kappa, N Latex FLC lambda (October 29, 2021)
  • K193047 — N Latex FLC kappa, N Latex FLC lambda (July 14, 2021)

Other clearances for product code CGR

  • K242190 — Access Cortisol; DxC 500i Clinical Analyzer (March 5, 2025)
  • K223038 — Access Cortisol (February 8, 2023)
  • K202136 — IDS Cortisol (April 13, 2021)
  • K202826 — IMMULITE® 2000 Cortisol (January 15, 2021)
  • K062626 — CORTISOL ELISA (December 20, 2006)
  • K060480 — VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND METAB (July 3, 2006)
  • K052359 — IBL CORTISOL LIA TEST KIT (October 3, 2005)
  • K050202 — CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS (February 9, 2005)
  • K042689 — NICHOLS ADVANTAGE CORTISOL (December 9, 2004)
  • K010790 — CORTISOL LIA (January 29, 2002)

FDA data resources